High Alert
Absorption: Well absorbed (92% of dose) through skin surface under transdermal patch, creating a depot in the upper skin layers. Release from transdermal system into systemic circulation ↑ gradually to a constant rate, providing continuous delivery for 72 hr.
Distribution: Widely distributed to tissues.
Half-Life: 17 hr after removal of a single application patch, ↑ to 21 hr after removal of multiple patches (because of continued release from deposition of drug in skin layers).
(analgesia)
ROUTE | ONSET | PEAK | DURATION |
---|---|---|---|
Transdermal | 6 hr‡ | 1224 hr | 72 hr‡ |
‡Achievement of plasma concentrations associated with analgesia. Maximal response and dose titration may take up to 6 days.
‡While patch is worn.
Contraindicated in:
Use Cautiously in:
CV: bradycardia, hypotension
Derm: sweating, erythema
Endo: adrenal insufficiency
GI: anorexia, constipation, dry mouth, nausea, vomiting
Local: application site reactions
MS: skeletal and thoracic muscle rigidity
Neuro: confusion, sedation, weakness, dizziness, restlessness
Resp: APNEA, bronchoconstriction, laryngospasm, RESPIRATORY DEPRESSION (INCLUDING CENTRAL SLEEP APNEA AND SLEEP-RELATED HYPOXEMIA)
Misc: allodynia, opioid-induced hyperalgesia, physical dependence, psychological dependence
Drug-drug:
Drug-Natural Products:
Hepatic Impairment
Renal Impairment
Lab Test Considerations:
Toxicity and Overdose:
Accidental overdose of opioid analgesics has resulted in fatalities. Before administering, confirm patient is opioid tolerant and clarify ambiguous orders.
FDA strongly encourages health care professionals to complete a REMS-compliant education program that includes all the elements of the FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain, available at www.fda.gov/OpioidAnalgesicREMSBlueprint. Information on programs can be found at 1-800-503-0784 or www.opioidanalgesicrems.com.
Instruct patient in how and when to ask for and take pain medication. Do not ↑ doses without discussing with health care professional; may lead to overdose. Discuss safe use, risks, and proper storage and disposal of opioid analgesics with patients and caregivers with each Rx. The Patient Counseling Guide is available at www.fda.gov/OpioidAnalgesicREMSPCG. Advise patient to read Medication Guide before starting therapy and with each Rx refill in case of changes.